Non-Steroidal or Opioid Analgesia Use for Children With Musculoskeletal Injuries

Summary

Musculoskeletal (MSK) injuries, including limb injuries, are the most common cause for Emergency Department (ED) visits for children with pain. Broken arms and legs are known to cause moderate to severe pain in most children, yet previous research shows that children's pain in the emergency department is still under-treated. Further, children are less likely to receive appropriate pain medicine than adults with similar injuries.

The purpose of this research study is to compare the effectiveness and safety of 3 different possible medication combinations, for the pain management of children with acute MSK limb injuries. The pain medicines the investigators are studying are ibuprofen (Advil/Motrin), acetaminophen (Tylenol/Tempra), and hydromorphone (Dilaudid).

This study will consist of 2 trials that will be run simultaneously. Eligible caregiver/ child pairs presenting to the emergency department with acute MSK limb injury will decide in which trial they wish to participate: the Opioid trial or the Non-Opioid trial. If they select the Non-opioid trial, they will have an equal chance of receiving either (a) Ibuprofen OR (b) Ibuprofen and acetaminophen. If they select the Opioid trial, they will have an equal chance of receiving either (a) Ibuprofen OR (b) Ibuprofen and acetaminophen OR (c) Ibuprofen and hydromorphone. Regardless of which study they choose, their child will, at minimum, receive Ibuprofen (Advil/Motrin) for their pain. All study medicines will be given in oral liquid form.

This study will help the investigators figure out which pain medicine or combination of pain medicines works best for children with limb injuries. Promotion of adequate acute pain treatment of children presenting to the ED may help prevent the known short and long-term effects of inadequately treated pain in children, including unpleasant memories, stress and anxiety upon future visits to healthcare, and compromised functional outcomes such as missed school.

Conditions

• Musculoskeletal Injury

Interventions

DRUG

Ibuprofen

10mg/kg, maximum 600mg; Oral liquid

DRUG

Acetaminophen

15mg/kg, maximum 1000mg; Oral liquid

DRUG

Hydromorphone

0.05mg/kg, maximum 5 mg; Oral liquid

DRUG

Acetaminophen placebo

Oral liquid

DRUG

Hydromorphone placebo

Oral liquid

Sponsors & Collaborators

• University of Manitoba

  collaborator OTHER

• Centre hospitalier de l'Université de Montréal (CHUM)

  collaborator OTHER

• University of Calgary

  collaborator OTHER

• The Hospital for Sick Children

  collaborator OTHER

• University of Ottawa

  collaborator OTHER

• Western University

  collaborator OTHER

• University of Alberta

  lead OTHER

Principal Investigators

• Samina Ali, MD · University of Alberta/Stollery Children's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

6 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-04-20

Primary Completion

2023-03-09

Completion

2023-03-22

Countries

• Canada

Study Locations